DeviceClearance

K013718

Substantially Equivalent

GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR

Applicant
Gynecare, A Div. of Ethicon, Inc.
Product code
OTO
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Somerville, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OTO

product code OTO
Injury
840
Total
840

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.